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FDA 510(k) Application Details - K973199
Device Classification Name
Catheters, Suction, Tracheobronchial
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510(K) Number
K973199
Device Name
Catheters, Suction, Tracheobronchial
Applicant
AMSINO INTL., INC.
833 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact
RICHARD Y LI
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Regulation Number
868.6810
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Classification Product Code
BSY
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More FDA Info for this Product Code
Date Received
08/26/1997
Decision Date
09/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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